Translation of nonclinical to clinical safety findings for 27 biotherapeutics-Reference-Cited by-同舟云学术

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Translation of nonclinical to clinical safety findings for 27 biotherapeutics

Published:2024-03 Issue: Volume:484 Page:116854
ISSN:0041-008X
Container-title:Toxicology and Applied Pharmacology
language:en
Short-container-title:Toxicology and Applied Pharmacology

Author:

Leach Michael W.,Rana Payal,Hu Wenyue,Mittapalli Rajendar K.,Pinkstaff Jason,Potter David,Qiu Xing Min,Ramaiah Lila,Rohde Cynthia,Xia Feng,Khan K. Nasir

Publisher

Elsevier BV

Reference42 articles.

1. FDA and industry collaboration: identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations;Ackley;Regul. Toxicol. Pharmacol.,2023

2. Clarification of terminology in drug safety;Aronson;Drug Saf.,2005

3. Gaps and challenges in nonclinical assessments of pharmaceuticals: an FDA/CDER perspective on considerations for development of new approach methodologies;Avila;Regul. Toxicol. Pharmacol.,2023

4. An analysis of the use of dogs in predicting human toxicology and drug safety;Bailey;Altern. Lab. Anim,2013

5. An analysis of the use of animal models in predicting human toxicology and drug safety;Bailey;Altern. Lab. Anim,2014

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